Methods for treating age-related macular degeneration

Patent metadata

Field	Value
Publication number	US-12371481-B2
Application number	US-202117378618-A
Country	US
Kind code	B2
Filing date	Jul 16, 2021
Priority date	Nov 7, 2014
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

A method is provided for reducing the treatment burden for patients who have an intraocular neovascular disorder, the method comprising administering a therapeutically effective amount of VEGF antagonist on a dosing schedule that includes treatment intervals of 8 and/or 12 weeks.

First claim

What is claimed is:

1. A method for treating age-related macular degeneration (AMD) in a patient in need thereof, the method comprising administering to the patient three individual doses of a VEGF antagonist at 4-week intervals, and thereafter administering to the patient an additional dose every 12 weeks or every 8 weeks, wherein each dose of the VEGF antagonist is at least 3 mg, wherein the VEGF antagonist is an anti-VEGF antibody comprising a variable heavy chain having the sequence as set forth in SEQ ID NO: 1 and a variable light chain having the sequence as set forth in SEQ ID NO: 2.

2. The method of claim 1 , wherein the VEGF antagonist is administered at 4-week intervals, and thereafter administering to the patient an additional dose every 12 weeks.

3. The method of claim 1 , wherein the VEGF antagonist is administered at 4-week intervals, and thereafter administering to the patient an additional dose every 8 weeks.

4. The method of claim 1 , wherein the VEGF antagonist is administered at 4-week intervals, and thereafter administering to the patient an additional dose every 12 weeks or every 8 weeks depending on the outcome of disease activity assessment, wherein the disease activity assessment includes determining the best-corrected visual acuity (BCVA), visual acuity (VA), central subfield thickness (CSFT) as measured by SD-OCT, and/or the presence of new or worsening intraretinal cysts/intraretinal fluid (IRC/IRF).

5. The method of claim 1 , wherein each dose of the VEGF antagonist is 3 mg.

6. The method of claim 1 , wherein each dose of the VEGF antagonist is 6 mg.

7. The method of claim 6 , wherein each dose of the VEGF antagonist is administered as a 50 μL intravitreal injection.

8. The method of claim 1 , wherein the VEGF antagonist comprises the sequence of SEQ ID NO: 3.

9. The method of claim 8 , wherein the VEGF antagonist is brolucizumab.

10. The method of claim 1 , wherein a 12-week treatment interval is switched to an 8-week treatment interval if the patient's disease activity is detected.

11. The method of claim 1 , wherein an 8-week treatment interval is switched to a 12-week treatment interval if the patient's disease activity is absent.

12. The method of claim 1 , wherein a 12-week treatment interval is switched to an 8-week treatment interval if the following criteria are met:
a) decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 16 compared to Baseline,
b) decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 16 compared to Week 12,
c) VA decline of ≥3 letters and CSFT increase ≥75 μm, at Week 16 compared to Week 12, and
d) new or worsening intraretinal cysts (IRC)/intraretinal fluid (IRF) at Week 16 compared to Week 12.

13. The method of claim 1 , wherein a 12-week treatment interval is switched to an 8-week treatment interval if the following criteria is met: decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 20, 32, or 44 compared to Week 12.

14. The method of claim 1 , wherein a 12-week treatment interval is switched to an 8-week treatment interval if the following criteria is met: decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 56, 68, or 80 compared to Week 12.

15. The method of claim 11 , wherein an 8-week treatment interval is switched to a 12-week treatment interval if the following criteria are not met:
a) decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 48 compared to Week 32, and
b) new or worsening intraretinal cysts (IRC)/intraretinal fluid (IRF) at Week 48 compared to Week 32.

Assignees

• Novartis Ag

Inventors

• Gekkieva Margarita
• Sallstig Peter
• Schmidt Werner
• Warburton James
• Weichselberger Andreas

Classifications

• C07K2317/94

  Stability, e.g. half-life, pH, temperature or enzyme-resistance · CPC title

• C07K2317/569

  Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody® · CPC title

• C07K2317/567

  Framework region [FR] · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/522

  CH1 domain · CPC title